MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

Catalog Number 04625315160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not returned.

Event Description

The customer stated that they received erroneous results when testing a patient with coaguchek xs professional meter serial number (b)(4).All meter results were dated (b)(6) 2001, but testing actually occurred on (b)(6) 2018.The meter date setting was not current.At 11:26 a.M., a sample from the patient was tested, resulting as 5.6 inr.At 11:30 a.M., a sample from the same finger of the patient was tested, resulting as 3.9 inr.At 11:34 a.M., a sample from a different finger of the patient was tested, resulting as 4.7 inr.A sample from the patient was tested also with an unknown laboratory test on (b)(6) 2018, resulting as 4.0 inr.No adverse events were alleged to have occurred with the patient.No actions were taken based on the meter results.The patient received treatment based on the laboratory test.The patient's therapeutic range is 2.0 - 4.0 inr.The patient is not anemic and does not have antiphospholipid antibodies.The patient does not receive heparin or direct thrombin inhibitors.The patient did not have any changes in warfarin dosage.The patient has had no changes in diet.The patient had pneumonia one week prior to (b)(6) 2018 and was taking tamiflu and an antibiotic.The patient has not had any abnormal bleeding or bruising.The customer did not know if internal controls on the meter passed.The customer's product was requested for investigation and replacement product was sent to the customer.Relevant retention test strips (lot 186865-12) were tested in comparison with the master lot coaguchek xs pt at roche (b)(4).For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were acceptable.The returned meter was measured with master lot strips in comparison to a retention meter and master lot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor 1 inr: 2.1 inr, donor 2 inr: 2.1 inr.Donor 1 hct: 44%, donor 2 hct: 48%.Testing results: donor #1: master lot: 2.1 inr, customer meter and master lot: 2.1 inr.Donor #2: master lot: 2.1 inr, customer meter and master lot: 2.2 inr.All inr values were within the specified maximum difference between measurements.The patient samples were always identified as blood.No error messages occurred.The returned material and the retention material meet specifications.None of the treatments/medications provided to the patient are currently known to interfere with the accuracy of the test results.Upon review of the meter memory, it was found that the date was set incorrectly, but the reported values of 4.7 inr, 3.9 inr and 5.6 inr could be observed.A possible cause of the result difference between the first and second values is the same finger was used for both tests.Product labeling instructs the customer to never perform another test using the same fingerstick.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7240496
• MDR Text Key: 99779885
• Report Number: 1823260-2018-00330
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 04625315160
• Device Lot Number: 18686512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR